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Monte Rosa Therapeutics (Nasdaq: GLUE), a clinical-stage biotechnology company based in Boston, announced on September 8, 2026, that its collaborator Novartis has initiated a Phase 2 clinical study for MRT-6160, also known as DDY391. In connection with the first patient visit of this study, Monte Rosa will receive a $50 million milestone payment from Novartis.
The Phase 2a/b study is a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the efficacy, safety, and tolerability of MRT-6160 in participants with Sjogren’s disease. The trial will assess up to 52 weeks of treatment to support dose selection for future Phase 3 development. The study identifier for this trial is NCT07737743 on ClinicalTrials.gov.
MRT-6160 is an investigational molecular glue degrader directed at VAV1, a key signaling protein located downstream of both T-cell and B-cell receptors. According to the company, preclinical and clinical data support the potential of MRT-6160 to address multiple immune-mediated diseases. In a prior Phase 1 study, the company stated that MRT-6160 demonstrated sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells after single and multiple-dose administration. The company also reported the suppression of key inflammatory biomarkers and noted that the administration was generally well tolerated with no serious adverse effects observed.
Sjogren’s disease is described by the company as a serious, progressive autoimmune disease affecting approximately 0.25% of the population. It impacts multiple organs and causes symptoms such as dryness, fatigue, pain, and an increased risk of lymphoma. The company noted that the heterogeneous nature of the disease often leads to it being unrecognized or misdiagnosed, with estimates suggesting that 50% of people with the condition are undiagnosed.
Under a global exclusive development and commercialization license agreement, Novartis holds exclusive worldwide rights to develop, manufacture, and commercialize MRT-6160 and other VAV1 molecular glue degraders. Novartis is responsible for all clinical development and commercialization activities, starting with Phase 2 studies. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon the initiation of Phase 2 studies. Novartis funds the Phase 2 studies, while Monte Rosa will co-fund any Phase 3 clinical development. Monte Rosa will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the United States.
Markus Warmuth, Chief Executive Officer of Monte Rosa Therapeutics, stated that the company is very pleased that Novartis is advancing MRT-6160 into clinical development for Sjogren’s disease. He added that the milestone reflects strong progress in the program and validates the potential of the company’s QuEEN product engine to address disease-driving proteins that have long been considered undruggable.
Additional studies are expected to evaluate the potential of MRT-6160 across other immune-mediated diseases. Monte Rosa remains eligible for additional Phase 2 study initiation milestones under the agreement.
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